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CompletedNCT03609203Updated Apr 4, 2022

Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training

An observational study in Allogeneic HCT Survivors, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Masonic Cancer Center, University of Minnesota · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.

02

Conditions studied

  • Allogeneic HCT Survivors
03

In context

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.

Eligibility criteria

Healthy Volunteers: must be the friends or relatives of the cancer patients enrolled in this study.

Inclusion Criteria:

  • HCT recipients

    • Age ≥ 18 years
    • Greater than 6 months after completing systemic multiagent chemotherapy (greater than 12 months for HCT participants) at the time of enrollment. Maintenance chemotherapy is allowed
    • In remission from cancer Off immunosuppression, or on a stable immunosuppression regimen with prednisone doses ≤ 20 mg daily, with no changes planned to the immunosuppression regimen during the study period
    • Karnofsky performance status ≥ 50% (Appendix III)
    • Platelet count ≥ 50,000 without transfusions
    • Absolute neutrophil count ≥ 1
    • Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)
    • Currently reside within the Minneapolis-St. Paul metro area
    • Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study
    • If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment
    • Willing and able to sign voluntary written consent

  • Healthy Controls

    • Age ≥ 18 years
    • Karnofsky performance status ≥ 50%
    • Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)
    • Currently reside within the Minneapolis-St. Paul metro area
    • If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment
    • Willing and able to sign voluntary written consent

Exclusion Criteria for both Cancer Survivors and Controls

  • Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed
  • Use of ≥ 20+ mg prednisone daily
  • Current or planned use of investigational drugs during the study period
  • Myocardial infarction or stroke within 6 months
  • Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html)
  • Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program
  • Are currently pregnant
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Other: 10 Weeks of Strength Trailing · Other: Group Nutrition Discussion: week 1, week 5 and week 10

  • Controls

    Other: 10 Weeks of Strength Trailing · Other: Group Nutrition Discussion: week 1, week 5 and week 10

Interventions

  • Other10 Weeks of Strength Trailing

    Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples

  • OtherGroup Nutrition Discussion: week 1, week 5 and week 10

    Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples

06

What researchers measure

Primary outcomes

  1. Self-reported outcomes of self-efficacy

    To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.

    Time frame: Week 10

Secondary outcomes

  1. Biomarkers of inflammaging in the blood

    To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls.

    Time frame: Week 10

07

Study locations

1 site
  • Masonic Cancer Center, University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03609203
Lead sponsor
Masonic Cancer Center, University of Minnesota
Responsible party
Sponsor
First posted
Aug 1, 2018
Start date
Sep 10, 2018
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Apr 4, 2022

Study contacts

Shernan G Holtan, MD
principal investigator · Division of Hematology, Oncology and Transplantation, University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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